Kornimate/medical-research-clean huggingface dataset:
a study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of risdiplam (ro7034067) given by mouth in healthy volunteers

Conditions: Spinal Muscular Atrophy

Summary: the objective of this study is to assess the safety and tolerability of risdiplam (ro7034067) in healthy people. the study will assess what the body does to risdiplam (ro7034067) and what risdiplam (ro7034067) does to the body. risdiplam (ro7034067) will be given by mouth in gradually increasing doses. the data from this study will help to define the dose to further explore risdiplam (ro7034067) in patients with spinal muscular atrophy.


Eligibility criteria:
inclusion criteria: * healthy men, aged 18 to 45 years of age, inclusive * body mass index (bmi) of 18 to 30 kilograms/meter square, inclusive exclusion criteria: * history or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs * history of malignancy in the past 5 years * a history of clinically significant hypersensitivity (e.g. drugs, excipients) or allergic reactions * any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first study drug administration * history or presence of clinically significant electrocardiogram (ecg) abnormalities or cardiovascular disease * clinically significant abnormalities in laboratory test results * confirmed resting pulse rate (pr) greater than 100 or less than 40 bpm * confirmed systolic blood pressure (sbp) greater than 140 or less than 90 mm hg, and diastolic blood pressure (dbp) greater than 90 or less than 50 mm hg * positive result on hiv1 and hiv2, hepatitis c (hcv) or hepatitis b (hbv) * history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmological, dermatological, hematological or allergic disease, metabolic disorder, hypofertility, cancer or cirrhosis * history or evidence of (neuro)muscular disorders * hypersensitivity to itraconazole, to any of the other ingredients, or to any other triazole antifungal * any other known contraindications to itraconazole
dental and medical office imet to reduce teen tobacco, alcohol, and drug use

Conditions: Use; Tobacco, Harmful; Alcohol Abuse; Drug Abuse

Summary: the purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new internet/intranet-based motivational enhancement therapy (imet) intervention that targets the use of tobacco, alcohol, and other drugs.

we have previously developed and tested in a treatment population a promising met program for alcohol and drug use. we will broaden the met intervention to also target tobacco use and convert the new materials into a self-administered format.

Eligibility criteria:
inclusion criteria: * 12-21 years old * coming for routine care exclusion criteria: * medically or emotionally unstable day of visit * already receiving behavioral health services * cannot read/understand english * will not be available for post-tests

Keywords: alcohol abuse marijuana abuse drug abuse tobacco use tobacco dependence
vascular and lipid effects of omega-3 fatty acids in people with moderately elevated triglycerides

Conditions: Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.


Eligibility criteria:
inclusion criteria: * triglycerides 150-500 mg/dl * age 21-65 years * generally healthy * body mass index (bmi) 20-39 kg/m2 exclusion criteria: * smoking * premenopausal (if female) * use of hormone replacement or oral contraceptives * use of lipid lowering or blood pressure medication * hypertension (blood pressure \> 150/95 mm hg) * peripheral vascular disease * heart disease, diabetes, or stroke * inflammatory disease (e.g. rheumatoid arthritis or crohn's) * elevated liver enzymes * high intake of omega-3 containing foods * allergy to adhesive or latex * use of aspirin, anticoagulants, or ssri

Keywords: triglycerides hypertriglyceridemia omega-3 n-3 eicosapentaenoic acid epa docosahexaenoic acid dha flow mediated dilation fish moderate hypertriglyceridemia
covid-19 amyotrophic lateral sclerosis (als) registry

Conditions: Covid19; Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a relentlessly progressive and fatal neurodegenerative disease characterized by progressive weakness involving limb, bulbar, and respiratory muscles.there is currently no information suggesting how covid-19 affects patients diagnosed with amyotrophic lateral sclerosis (als). this is especially important as respiratory compromise is common in als patients and can complicate the clinical course as covid-19 could lead to respiratory failure and need for intubation. we intend that this registry will guide our understanding of how covid-19 affects patients with als.

the purpose of this registry is to assess the incidence and prevalence of covid-19 in als patients, the effect of covid-19 on als disease trajectory, and the impact, if any, of edaravone, riluzole and other concomitant medication used in als like albuterol and dextromethorphan/quinidine (nuedexta) on these parameters. covid-19 incidence and prevalence in the als population will be assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry.

Eligibility criteria:
inclusion criteria: * diagnosis of als and * a confirmed covid-19 infection determined by: 1. positive sars-cov-2 viral rna pcr test and/or 2. positive serology antibody testing for sars-cov-2 exclusion criteria: * no als diagnosis * no confirmed covid-19 infection
evaluation of artesunate in infants being treated for severe malaria

Conditions: Malaria

Summary: this is essentially a laboratory study that is an addendum to an ongoing prospective phase 4 multicenter observational study titled: "safety and efficacy of artesunate in pregnant women and infants (artemum)" being conducted in france. infants, the parents of whom provided consent to have data collected from their child as part of the artemum study, will have an additional blood sample collected when other standard of care blood specimens are collected during the 2-day period after the start of intravenous (iv) artesunate treatment. a maximum of 4 samples will be taken and plasma will be isolated and stored frozen until analysis for plasma artesunate and dihydroartemisinin (dha) concentrations. red blood cells will also be frozen for further analysis (for example kelch-13 mutations). in addition, a standard of care blood sample will be collected approximately one month post treatment for clinical laboratory tests.

this is essentially a laboratory study that is an addendum to an ongoing prospective phase 4 multicenter observational study titled: "safety and efficacy of artesunate in pregnant women and infants (artemum)" being conducted in france. parents of infants under 2 years of age who provided consent to participate in the artemum study will be asked to provide consent for their child to this laboratory study providing the infant was eligible for the artemum study. during the first 48 hours after the start of iv artesunate treatment, a maximum of 4 samples of blood will be collected when other standard of care samples are being collected. with regard to blood collected for standard of care, it is recognized that samples between 0.25 and 5 hours post doses will be the most useful for pharmacokinetic (pk) analysis due to the 30-to-45-minute half-life of dha. plasma will be isolated and frozen until submission to the central laboratory for artesunate and dha plasma concentrations. in addition, a standard of care blood sample will be collected approximately one month post treatment for clinical laboratory tests. the recommendation by the world health organization (who) is followed in france not only for safety (anemia) but also for relapse. clinical laboratory test results and other data to be included in the analysis will be abstracted from the case report forms (crfs) from the artemum study.

Eligibility criteria:
inclusion criteria: * parental consent provided to the artemum study * parental consent provided to participate in this pk laboratory study * infants \< 2 years of age with malaria (positive blood by polymerase chain reaction (pcr) or thin or thick smear or rapid diagnostic test (rdt), or any combination of those) treated by at least 1 dose of intravenous artesunate exclusion criteria: * hemoglobin \< 7.0 g/dl at the time when additional blood sample for pk assessment will be drawn as part of standard of care

Keywords: artesunate infant
coronary ct angiography to predict vascular events in noncardiac surgery patients cohort evaluation (cta -vision) study

Conditions: Cardiovascular Disease

Summary: worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of these patients will suffer a major vascular complication. despite the magnitude of this problem our capacity to predict these events is limited. although perioperative myocardial infarction (mi) is the most common major perioperative cardiac complication, little is known about its pathophysiology. coronary computed tomography angiography (cta) is a potential non-invasive method for the detection of coronary artery disease and cardiac risk stratification in the non-operative setting; however, the value of this test to enhance risk prediction among patients scheduled for noncardiac surgery is unknown. this study is an international prospective cohort study to determine among patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery: 1) if preoperative coronary cta has additional predictive value for the occurrence of major perioperative cardiac events and 2) the underlying coronary anatomy associated with perioperative mis.


Eligibility criteria:
inclusion criteria: * age \>=45 years * undergoing non cardiac surgery requiring an overnight stay and general or regional anaesthetic * at least one of: 1. coronary artery disease (cad) 2. peripheral vascular disease (pvd) 3. history of stroke 4. history of congestive heart failure (chf) 5. combination of at least 3 of: * age \>= 70 years * history of treatment for hypertension * history of treatment for dyslipidemia * smoking in last 2 years * diabetic and currently taking insulin or oral diabetic drugs * history of transient ischemic attack (tia) exclusion criteria: * contraindications to cta
limb girdle muscular dystrophy (lgmd) natural history

Conditions: Muscular Dystrophies, Limb-Girdle (GENETICALLY CONFIRMED)

Summary: the purpose of this study is to understand more about limb-girdle muscular dystrophy. therefore, the investigators would like to track the following information collected once a year from patients with genetically confirmed lgmd: quality of life questionnaires, muscle strength, motor function, routine examination, assessment of patient (or parent) understanding of lgmd, and serum (blood) for growth factors, cytokines, and biomarkers (all parts of your blood). by tracking this information, we hope to be able to understand more about the diagnosis, progression and natural history of this disorder.


Eligibility criteria:
inclusion criteria: * you have a genetically confirmed diagnosis of limb girdle muscular dystrophy * you must be at least 6 years of age or older (if under 18 you will need parental consent) * you must be able to travel to the study site * you must be able to provide a dna/gene testing report that confirms a diagnosis of lgmd exclusion criteria: * you or your child do not have a diagnosis of lgmd * your child is under age 6 * you or your child are not able to travel to the study site

Keywords: genetically confirmed limb girdle muscular dystrophy
assiut university registry for acs patients during covid-19 pandemic

Conditions: ACS-COVID-19-Assiut

Summary: to register pathological events occurring to all acute coronary syndrome patients coming to assiut university heart hospital through one year during covid- 19 pandemic

in the face of the quickly evolving coronavirus disease 2019 (covid-19) pandemic, many health-care systems around the globe have modified their routine management of patients presenting with acute cardiovascular emergencies including patients with acs.a unifying theme in the new management strategies is the adoption of new restrictive measures to meet the challenges of increased risk of infection of health-care workers; limited numbers of beds, shortage of personal protective equipment (ppe), inadequate number of protected catheterization rooms; and the clinical overlap between acs and covid-19 infection in some of patients. in developing countries, with an already strained health system due to economic problems, the situation is more challenging and needs the formulation of efficient protocols that can accommodate several medical and socioeconomic challenges. egypt, with an estimated population of 100 million, is facing exceptional challenges during the covid-19 crisis. because large scale use of polymerase chain reaction (pcr) test for sars-cov-2 in a large population is a problem, the prevalence of covid-19 infection in egypt is unknown. furthermore, the supply of ppe falls far short of demands with lack of professionally protected cardiac catheterization rooms. with progression of the pandemic in such a large population, care of covid-19 patients is expected to rapidly overwhelm the supplies, beds, and staff available in egyptian hospitals. the cardiology department in assiut university hospital has revised the management protocols for acs patients and implemented new management protocols both for patients with st-segment elevation myocardial infarction (stemi) and non-st-segment elevation acute coronary syndromes (nste-acs).

Eligibility criteria:
inclusion criteria: * patients presenting with symptoms or ecg indicative of acute coronary syndrome admitted to assiut heart hospital exclusion criteria: * the only exclusion criteria is refusal of the patient to participate in the study
lipid lowering with highly potent statins in hyperlipidaemia with type 2 diabetes patients

Conditions: Hypercholesterolemia With Concomitant Type 2 Diabetes

Summary: the purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. hypercholesterolemia patients • patients who have not achieved the target control levels of ldl-c in the "japan atherosclerosis society guidelines for prevention of atherosclerotic cardiovascular diseases 2007" 2. type 2 diabetes patients * patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication * patients who received constant therapy for three months before registration and have no plan for therapy change * patients with kept hba1c level (japan diabetes society \[jds\] level) of less than 7.0% (or, national glycohemoglobin standardization program \[ngsp\] level of less than 7.4%) within three months before registration * patients receiving or not receiving medication at present 3. patients giving voluntary written consent to participate in the study 4. male or female patients at 20 years or older exclusion criteria: 1. patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration 2. patients with severe hypertension (systolic blood pressure \[sbp\] ≥ 180 mmhg or diastolic blood pressure \[dbp\] ≥ 110 mmhg) 3. patients with type 1 diabetes 4. patients judged to have familial hypercholesterolemia 5. patients with a serum triglyceride level of ≥ 400 mg/dl 6. patients who had the onset of cardiovascular or cerebrovascular disease within three months 7. patients with serious heart failure (nyha classification iii - iv) 8. patients with a history of hypersensitivity to statins 9. patients with a history of drug-induced myopathy 10. patients with severe complication of diabetes 11. patients receiving insulin 12. patients with serious liver or kidney disease 13. patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan 14. patients who are or may be pregnant 15. patients judged by the investigators to be ineligible for participation in the study for any other reason
grafixcore®: open-label study to evaluate the safety and efficacy of grafixcore® for complex diabetic foot wounds

Conditions: Complex Diabetic Foot Wounds

Summary: a multicenter, open-label, single-arm study to evaluate the safety and efficacy of grafixcore® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.


Eligibility criteria:
inclusion criteria: 1. between 18 years and 85 years of age inclusive, as of the date of screening 2. confirmed diagnosis of type i or type ii diabetes 3. index wound graded in the texas classification system as grade ii-iii, stage a or c (without active infection) 4. wound is located on the foot below the malleoli 5. wound accommodates up to three (3) 5 cm x 5 cm pieces of grafixcore® that completely cover the wound 6. patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule 7. patient has adequate circulation to the foot as documented by either: * ankle brachial index (abi) ≥ 0.5 and ≤ 1.2, or * in patients with non-compressible ankle vessels, a toe bp ≥ 40 mmhg or tcpo2 \> 30 mmhg, or * skin perfusion pressure \> 30 mmhg exclusion criteria: 1. index wound is of non-diabetic pathophysiology 2. gangrene is present on any part of the affected foot 3. index wound is over a charcot deformity 4. the longest dimension of the index wound exceeds 15 cm at the baseline visit 5. patient has a glycated hemoglobin a1 (hba1c) level of \>14% 6. requiring intravenous (iv) antibiotics to treat the index wound infection at enrollment 7. patient has a wound within 15cm of the index ulcer identified for study consideration 8. patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents 9. patient is human immunodeficiency virus (hiv) positive or has acquired immune deficiency syndrome (aids) 10. current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site 11. patient has active malignancy other than non-melanoma skin cancer 12. patient's random blood sugar is \>450 mg/dl at screening 13. patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the investigator 14. pregnant women 15. patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening 16. patient has allergy to primary or secondary dressing materials used in this trial 17. patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies 18. in the opinion of the investigator, the patient is unsuitable for participation in the study

Keywords: complex wound diabetic foot ulcer dfu grafixcore exposed tendon exposed bone allograft tissue
a study to explore the role of gut flora in als

Conditions: ALS; Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding als

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding als

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers). 3. diagnosis of als exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
novel myofunctional water bottle to reduce osa and snoring study

Conditions: Obstructive Sleep Apnea; Snoring

Summary: this research study is being done to determine whether the repetition and resistance from the daily use of the myofunctional therapy (mt) nozzle will improve obstructive sleep apnea and primary snoring.


Eligibility criteria:
inclusion criteria: * patients with mild-moderate obstructive sleep apnea and snoring. * diagnosis of mild to moderate obstructive sleep apnea with apnea hypopnea index 5-29 events/hour confirmed within last 2 years with an in-lab diagnostic polysomnography or home sleep apnea test. * ownership of a smartphone and willingness to use a smartphone application to automatic log daily water intake. * willingness and ability to discontinue the currently prescribed osa treatment for at least 3 days prior to testing. * age greater than or equal to 18 years exclusion criteria: * individuals not diagnosed with obstructive sleep apnea and snoring. * significant weight change (10% change in body weight in kg) from the time of the osa diagnosis until the study initiation. * persistent excessive daytime sleepiness (epworth sleepiness scale \> 10), despite treatment of osa * significant medical comorbidities requiring restricted oral fluid intake - decompensated heart failure, end stage renal disease, end stage liver disease, hyponatremia (s. na \ times/night. * unable or unwilling to participate in study procedures. * previous upper airway surgeries significantly modifying upper airway anatomy such as uppp, apnea surgeries, oral and throat cancer surgeries or radiation. * known congenital or acquired diseases significantly affecting upper airway anatomy such as down's syndrome, oral and throat cancer. * bmi \>40 kg/m\^2. * currently treating osa with hypoglossal nerve stimulator.